CLINICAL TRIALS

FIX-HF-5C

Acronym: Evaluate Safety and Efficacy of the Optimizer System in Subjects with Moderate-to-Severe Heart Failure

Purpose: Researchers assessed the safety and efficacy of cardiac contractility modulation with a device (Optimizer, Impulse Dynamics) in patients with heart failure with ejection fraction between 25% and 45%

Summary: At 24 weeks, peak VO2 was 15.042 mL O2/kg/min in the cardiac contractility group and 14.206 mL O2/kg/min in the control group. The probability that cardiac contractility modulation is superior to control was 0.989, exceeding the criterion for statistical significance of 0.975. Also at 24 weeks, the treatment group had better Minnesota Living with Heart Failure questionnaire score and had better performance on the 6-minute walk distance test.